A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
Status: | Completed |
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Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 1/25/2019 |
Start Date: | March 2015 |
End Date: | October 2015 |
A Phase 2a Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
The objectives of this study are to evaluate the safety and tolerability of Zimura™
intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF)
therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF)
therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the
previous twelve (12) months) subjects of either gender aged 50 years or above with a
diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye)
in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea®
2 mg/eye).
Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at
Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total
retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3
compared to screening as measured by indocyanine green angiography (ICGA), and laboratory
values.
previous twelve (12) months) subjects of either gender aged 50 years or above with a
diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye)
in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea®
2 mg/eye).
Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at
Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total
retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3
compared to screening as measured by indocyanine green angiography (ICGA), and laboratory
values.
Inclusion Criteria:
- Subjects of either gender aged ≥ 50 years
- Diagnosis of IPCV
- Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8
injections in the previous twelve (12) months
Exclusion Criteria:
- Any intraocular surgery or thermal laser within three (3) months of trial entry
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection in the twelve (12) weeks prior to entry
- History of any of the following conditions or procedures in the study eye:
Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
trabeculectomy), glaucoma drainage device, corneal transplant
- Previous therapeutic radiation in the region of the study eye
- A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy
and/or leakage from retinal vasculature in a subject with diabetes mellitus)
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